| Title: |
Is this test fit-for-purpose? Principles and a checklist for evaluating the clinical performance of a test in the new era of in vitro diagnostic (IVD) regulation |
| Authors: |
Lord, S. J.; Horvath, A. R.; Sandberg, S.; Monaghan, P. J.; C, M. C.; Reim, M.; Tolios, A.; Mueller, R.; Bossuyt, P. M. |
| Contributors: |
National Health and Medical Research Council (NHMRC) Clinical Trials Centre, University of Sydney, Sydney, Australia. New South Wales Health Pathology Department of Chemical Pathology, Prince of Wales Hospital and School of Medical Sciences, University of New South Wales; School of Public Health, University of Sydney, Australia. The Norwegian Quality Improvement of Primary Care Laboratories (NOKLUS), Department of Public Health and Primary Health Care, University of Bergen; and Laboratory of Clinical Biochemistry, Haukeland University Hospital, Norway. Department of Clinical Biochemistry, The Christie NHS Foundation Trust, Manchester, United Kingdom. Division of Cancer Sciences, The University of Manchester, Manchester, United Kingdom. Head of Department of Clinical Chemistry and Laboratory Medicine, Leiden University Medical Center, The Netherlands and Chair of EFLM C-European Regulatory Affairs, the Netherlands. Clinical Operations, Roche Diagnostics International, Rotkreuz, Switzerland. Department of Blood Group Serology and Transfusion Medicine, Medical University of Vienna, Austria. Medical Affairs, Abbott Core Diagnostics, Wiesbaden, Germany. Professor of Clinical Epidemiology, Department of Clinical Epidemiology, Biostatistics & Bioinformatics, Academic Medical Center, University of Amsterdam, the Netherlands. |
| Publication Year: |
2025 |
| Collection: |
The Christie School of Oncology: Christie Research Publications Repository |
| Description: |
Recent changes in the regulatory assessment of in vitro medical tests reflect a growing recognition of the need for more stringent clinical evidence requirements to protect patient safety and health. Under current regulations in the United States and Europe, when needed for regulatory approval, clinical performance reports must provide clinical evidence tailored to the intended purpose of the test and allow assessment of whether the test will achieve the intended clinical benefit. The quality of evidence must be proportionate to the risk for the patient and/or public health. These requirements now cover both commercial and laboratory developed tests (LDT) and demand a sound understanding of the fundamentals of clinical performance measures and study design to develop and appraise the study plan and interpret the study results. However, there is a lack of harmonized guidance for the laboratory profession, industry, regulatory agencies and notified bodies on how the clinical performance of tests should be measured. The Working Group on Test Evaluation (WG-TE) of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) is a multidisciplinary group of laboratory professionals, clinical epidemiologists, health technology assessment experts, and representatives of the in vitro diagnostic (IVD) industry. This guidance paper aims to promote a shared understanding of the principles of clinical performance measures and study design. Measures of classification performance, also referred to as discrimination, such as sensitivity and specificity are firmly established as the primary measures for evaluating the clinical performance for screening and diagnostic tests. We explain these measures are just as relevant for other purposes of testing. We outline the importance of defining the most clinically meaningful classification of disease so the clinical benefits of testing can be explicitly inferred for those correctly classified, and harm for those incorrectly classified. We introduce the key principles ... |
| Document Type: |
article in journal/newspaper |
| Language: |
English |
| Relation: |
https://doi.org/10.1080/10408363.2025.2453148; https://christie.openrepository.com/handle/10541/627854; Critical Reviews in Clinical Laboratory Sciences |
| DOI: |
10.1080/10408363.2025.2453148 |
| Availability: |
https://doi.org/10.1080/10408363.2025.2453148; https://christie.openrepository.com/handle/10541/627854 |
| Accession Number: |
edsbas.B0E80022 |
| Database: |
BASE |